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GVAX® Vaccine for Prostate Cancer vs Docetaxel & Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer

This study has been terminated.
(Based on futility analysis showing <30% chance of meeting primary endpoint.)
Information provided by:
Cell Genesys Identifier:
First received: August 16, 2004
Last updated: November 3, 2008
Last verified: November 2008
The purpose of this study is to compare the duration of survival between GVAX® immunotherapy for prostate cancer and chemotherapy treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases, and who have not been treated with chemotherapy in the past.

Condition Intervention Phase
Prostate Cancer Biological: Immunotherapy with allogeneic prostate vaccine Drug: Chemotherapy (Taxotere and prednisone) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Open-Label Study of CG1940 and CG8711 Versus Docetaxel and Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer Who Are Chemotherapy-Naïve

Resource links provided by NLM:

Further study details as provided by Cell Genesys:

Primary Outcome Measures:
  • Survival [ Time Frame: 0 ]

Secondary Outcome Measures:
  • Bone pain and bone related events [ Time Frame: 0 ]

Enrollment: 626
Study Start Date: July 2004
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Standard of care - chemotherapy
Drug: Chemotherapy (Taxotere and prednisone)
Chemotherapy (Taxotere and prednisone)
Experimental: 1
Biological: Immunotherapy with allogeneic prostate vaccine
Immunotherapy with allogeneic prostate vaccine


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate
  • Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy
  • Detectable metastases
  • Any Gleason score
  • ECOG performance status 0-2

Exclusion Criteria:

  • Prior treatment with chemotherapy
  • Prior Immunotherapy
  • Prior treatment with gene therapy
  • Significant cancer related pain
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00089856

  Show 126 Study Locations
Sponsors and Collaborators
Cell Genesys
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Cell Genesys, Inc, Cell Genesys, Inc. Identifier: NCT00089856     History of Changes
Other Study ID Numbers: G-0029
Study First Received: August 16, 2004
Last Updated: November 3, 2008

Keywords provided by Cell Genesys:
Allogeneic cells
Advanced Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal processed this record on August 22, 2017